Implantable valve system

ABSTRACT

An implantable valve having a valve element or leaflet and a base that is attachable to a vessel wall using a connector such as a screw, pin or a staple. The valve can be implanted using a catheter to position the valve in a desired location and drive the connector into the vessel wall. The valve can be used as a venous valve to control blood flow within the veins, arteries, heart or the aorta of a patient.

BACKGROUND OF THE INVENTION

Venous valves can improve the severe symptoms of patients with postthrombotic syndrome suffering from swelling and ulcerations of theirlegs. This condition can be caused by stenosis and occlusions of theveins and deterioration of the venous valves. Certain techniques havebeen developed to surgically restore incompetent valves or to implantdevices that aid in such restoration. However, there remain manysituations in which a valve is compromised to the extent that theseoptions are not effective and valve replacement must be considered. Byreplacement of the venous valves, the capillary venous pressure can bedecreased in this group of patients eventually improving theircondition.

Venous valves have been proposed that consist of a stent device combinedwith a moving valve being mounted to the stent. However, stents canreduce the effective orifice area of the valve which increases thetransvalvular pressure gradient. A further drawback to this valve isthat a stent has fixed dimensions and remains in contact with the totalcircumference of the inner venous surface which, therefore, can irritatea large amount of the venous wall, especially the endothelium. This canbe followed by intimal hyperplasia and thrombosis. Further, trauma tothe wall of the vein is induced by shear stress between the wallcomponents and the stent, because the venous diameter changes normally.The failure to accommodate growth of the patient is particularlyproblematic for children undergoing valve replacement, for example. Acontinuing need exists, therefore, for improvements in valve replacementsystems and in methods for placement of such valves.

SUMMARY OF THE INVENTION

The present device relates to an implantable valve having a valveelement that is attached to region of the a vessel wall with a tissueconnector. The valve can be placed within a body lumen using endoluminaltechniques such as a percutaneous catheter. The valve element can beformed with a biocompatible material such as plastic (e.g., PTFE) with agenerally oval or circular shape. Materials such as textile fabric anddonor tissue, such as fascia lata, for example, can also form the valveelement. The valve element rotates relative to a position on the vesselwall where the connector is located and moves between open and closedpositions to permit fluid flow in one direction and prevent fluid flowin the opposite direction.

The valve element can have a curved surface, with the generally convexside of the valve element facing against the preferential direction offlow of fluid within the lumen in which the valve is placed. Theopposite side of the valve element can consequently have a concaveshape. A preferred embodiment of the valve element uses a frame toreinforce the element. The periphery is preferably soft, however, toprevent vessel wall damage. The valve element generally has a diameterin a range between 2 mm and 45 mm, and a thickness between 0.2 mm and3.0 mm.

The valve element or leaflet is attached to a stationary base such thatthe leaflet can move or rotate relative to the base. The base isattached to the vessel wall with a connector such as a pin, a screw, astaple, and/or an adhesive. In the event that open implantation isperformed, a surgical suture can also be used as the connector. Theconnector can be used to attach the valve element to the base. In apreferred embodiment the base and the valve element can be formed as aunitary structure in which the valve element has a hinge region toprovide for rotation of the valve element relative to the base.

A preferred embodiment of the invention uses a catheter to position thevalve at a site within a body lumen and to attach the valve to a pointon a wall of the lumen. The catheter can employ a system that attachesthe valve to the vessel wall in which the catheter has a driver at thedistal end that attaches the connector to the lumen wall. The cathetercan have a guide that is used to position the distal end of thecatheter, the guide and/or the connector for proper anchoring of thevalve to the lumen. The guide can be a cord that extends through anothercatheter lumen or a sheath around the catheter that is connected at oneend to the distal end of the catheter such that the user canmechanically pull the cord to bend the distal end of the catheter andconsequently move the connector from one side of the lumen to theopposite side so that the portion of the connector that is to penetratethe vessel wall is properly oriented so as to be driven and securelyattached. A release mechanism to detach the system from the valve and/orconnector after placement can also be used.

Alternately, the valve can have a base with a connector to attach thevalve to a lumen wall and a tubular wall connected to the base. Thetubular wall has a proximal end with a proximal opening and a distal endwith a distal opening. When implanted into a lumen, flow from the distalend to the proximal end forces the tubular wall into an open positionthereby allowing flow through the tube while flow from the proximal endto the distal end forces the tubular wall into a closed position,thereby preventing flow in this direction. The valve can be shaped as awedge shaped tube or as a curve shaped tube. The curve shaped tube caninclude a crease portion which allows the tube to collapse in thepresence of back flow, thereby preventing back flow from entering thetube. The valve can be made from a silicone material.

The valve can also have a base with a connector to attach the valve to alumen wall, a leaflet and a hinge connecting the base and the leaflet.The leaf or leaflet can be formed with an oval shape. The leaflet canhave a concave shape. The leaflet can also have a rim and a centerportion wherein the rim is thinner than the center portion. The valveincludes a reinforcement frame which can be a metal filament. The valvecan include a fabric material connecting the leaflet and the base. Thefabric material can include a first layer and a second layer. Areinforcement member can be located between the first layer and thesecond layer.

BRIEF DESCRIPTION OF THE DRAWINGS

The foregoing and other objects, features and advantages of theinvention will be apparent from the following more particulardescription of preferred embodiments of the invention, as illustrated inthe accompanying drawings in which like reference characters refer tothe same parts throughout the different views. The drawings are notnecessarily to scale, emphasis instead being placed upon illustratingthe principles of the invention.

FIG. 1 illustrates a cross sectional view of a valve mounted within avessel and attached to the vessel wall.

FIG. 2 shows a top view of a valve mounted within a vessel.

FIGS. 3A and 3B illustrate partial perspective and top view of the valveof FIG. 1 in an open position.

FIG. 3C illustrates a mesh of a leaflet.

FIG. 3D illustrates tissue adhering to the struts of the mesh of FIG.3C.

FIG. 4 shows the mounting of the valve within a vessel using animplantation device.

FIG. 5 illustrates the implantation device and valve within a sheath.

FIG. 6 illustrates a tube placed in a vessel in an open position.

FIG. 7 illustrates a tube placed within a vessel in a closed position.

FIG. 8 illustrates a top view of the tube of FIG. 7.

FIGS. 9A and 9B illustrate a wedge shaped tube in a side and front view,respectively.

FIGS. 10A and 10B illustrate a curve shaped tube in a side view andfront view, respectively.

FIG. 11 illustrates a front view of a valve.

FIG. 12 illustrates a side view of a valve.

FIG. 13 illustrates an alternate embodiment of a side view of a valve.

FIG. 14 shows a cross sectional view of a valve.

FIG. 15 shows a valve mounted within a vessel in a closed position.

FIG. 16 illustrates a cross sectional view of the proximal end of thevalve of FIG. 15.

FIG. 17 illustrates a valve mounted within a vessel in an openedposition.

FIG. 18 shows a cross-sectional view of the proximal end of the valve ofFIG. 17.

FIG. 19 illustrates a cross-sectional view of a valve having an openingmechanism.

FIGS. 20A and 20B illustrate a cross sectional view of a valve having anopening mechanism in an open and a closed position, respectively.

FIG. 21 illustrates a valve having a concave curved portion.

FIGS. 22 and 23 show the valve of FIG. 21 in an open position and aclosed position, respectively.

FIG. 24 illustrates an alternate valve of FIG. 21.

FIG. 25 shows a valve attachment mechanism.

DETAILED DESCRIPTION OF THE INVENTION

FIG. 1 illustrates a valve, identified generally as 10. In a preferredembodiment, the valve 10 is a venous valve for placement within a vein.The valve 10 can include a valve element 20 and a base 18, where thevalve element or leaflet 20 is connected to the base 18 by a movablejoint such as a hinge 15.

The valve 10 can be attached within a vessel having a vessel wall 14.The valve 10 can be attached to the vessel wall 14 by a tissue connector12 which can include a pin, a screw or a staple, for example. Theconnector 12 can connect the valve 10 by its base 18 to the vessel wall14. When the connector 12 is placed into the vessel wall 14, only asmall portion of the connector 12 contacts the endothelium of the vesselwall 14 and the blood within the vessel. With such a configuration ofthe connector 12, there is less trauma to the wall 14 compared to theuse of a stent, for example.

The valve 10 can also include a second connector 34. The secondconnector 34 can also attach the valve 10 to the vessel wall 14 throughthe base 18. The second connector 34, however, acts to stabilize thevalve 10 and prevent twisting or turning of the valve 10 within thevessel when subjected to varying to fluid flow pressure.

FIG. 2 illustrates a top view of the valve 10 attached to the vesselwall 14. The valve 10 can be made from a non-thrombogenic matter such asa plastic material (eg. PTFE or silicone), or other biocompatiblematerials. Other materials can also be used such as textile fabric ortissue from the patient. Material such as fascia lata, or pericardiumcan be taken from donors, as cadavers or from animals like pigs or canbe produced by tissue engineering procedures. Fibroblast and endothelialcell cultures derived from human, bovine, and ovine sources can beseeded on biodegradable (glycolic acid) meshes can create valveleaflets. Xenograft leaflets can be made of human fibroblasts and bovineendothelial cells, and allograft leaflets can be made of bovine cellsengineered in vitro. The leaflet 20 of the valve 10 can include at leastone valve reinforcement frame 16. The valve frame 16 can help to preventcollapse of the valve 10 and increases the strength of the leaflet 20.The valve 10 can also include a rim 22. Preferably, the rim 22 of theleaflet 20 is formed of a compliant material to prevent damage to thevessel wall 14 during valve 10 motion and to form a tight junctionbetween the wall 14 and valve 10 when the valve 10 is in a closedposition.

A valve 10 having a compliant rim 22 allows physiological changing ofthe vessel wall 14 diameter without the valve 10 losing its function.The use of the valve 10 having a compliant rim 22 within a vessel cantherefore offer a benefit over the use of a stent within the vessel. Asthe diameter of the vessel changes, the valve 10 can accommodatealteration of the vessel diameter within a certain range, therebymaintaining its function. The material of the leaflet and the rim 22 canfold around the valve frame 16 to accommodate the inner lumen of thevessel wall 14 when the valve 10 is in an opened state. The folding ofthis material and the rim 22 can accommodate different vessel diameters.Conversely, a stent in contact with the total circumference of thevessel wall during changes in the diameter of the vessel can causestress on the wall surface. The valve element has a substantially ovalshape with a diameter along the longitudinal axis that is preferably inthe range between 2 mm and 2.5 cm. For certain applications the valveelement can have a diameter of up to 45 mm. Such a valve element can beused in the heart. The thickness of the valve element is preferablybetween 0.2 mm and 3 mm.

FIGS. 3A and 3B show the valve 10 in an open position. Fluid flow 24past the valve 10 can cause the leaflet 20 of the valve 10 to rotateabout or flex on its hinge 15. The hinge 15 connects the leaflet 20 tothe base 18 and provides flexibility between the components 18, 20. Thestiffness of the hinge 15 can be chosen such that flow of the fluid 24past the valve 10 within the vessel can force the valve 10 to open. Whenflow has ceased, the valve 10 can return to a closed position.

FIGS. 3A and 3B also illustrate the leaflet 20 of the valve 10 flexingaround the valve reinforcement 16. The leaflet 20 of the valve 10 canfold around the valve reinforcement 16 to accommodate the geometry ofthe inner lumen of the vessel wall 14 when the valve 10 is in an openstate. Such folding can accommodate varying vessel wall diameters.

In one embodiment, the leaflet 20 of the valve 10 is made of a mesh 180having struts 182, as illustrated in FIG. 3C. The mesh 180 can be formedfrom a woven plastic filament material, for example. The mesh can alsobe formed of flexible elastic such as Nitinol, or can be formed of abiodegradable material such as Polylactid.

Tissue cells are used to surround the mesh 180 to form a leafletsurface. In one embodiment, prior to implanting the leaflet valve into apatient, cells are cultured on the mesh 180 to create a surface ofliving cells. These cells can be stem cells or endothelium cells fromthe recipient patent. In another embodiment, the leaflet valve isimplanted into the patient without cultured cells. The openings in themesh 180 are then closed or filled by cells which adhere to and grow onthe struts 182 of the mesh 180. The cells can form an endothelium layer188. Tissue 184 and elastic fibers 186 can fill the voids within themesh 180, as illustrated in the enlarged view of FIG. 3D.

FIG. 4 illustrates a percutaneously implantable valve 10 being attachedto the vessel wall 14. To attach the valve 10 to the vessel wall 14, animplantation device 46 can be used which can include a double lumencatheter 26, for example. The catheter 26 can include a connector driveror axle 48, for affixing the connector 12 to the vessel wall 14, and aguide 50 for adjusting the location of the driver 48. As shown, a firstlumen 38 of the catheter 26, can accommodate the movement of the driver48 which can be a flexible core 28. The flexible core 28 can be madefrom plastic, Nitinol, or stainless steel, for example. The flexiblecore 28 has sufficient axial and/or rotational stiffness so that it canbe used to drive the connector 12 into the vessel wall 14. The catheter26 can also include a catheter connector 52 to connect the valve 10 tothe catheter distal tip 42 for introduction into the vessel. A releasemechanism can also be included to allow the user to release the catheterfrom the connector after placement.

A second catheter lumen 40 can include the guide 52 which can be a cable30. The cable 30 can be attached to the catheter tip 42 by a cableconnector 32. The cable 30 can control the bending of the catheter 26 toallow placement of the valve 10 in a desired location and attachment ofthe valve 10 to the vessel wall 14. The cable 30 can be a flexiblematerial. Alternately, the cable 30 can be a stiff wire which can beused to push the catheter 26 into a straight shape. The second lumen 40terminates at a distance of about 0.2-25 mm from the distal end 42 ofthe catheter to accommodate the rotational displacement of the distalend of the catheter from a first side of the lumen to the opposite sideof the lumen such that the connector is oriented properly relative tothe wall for insertion. For example, if the valve element has a diameterof 10 mm, the distance from the end of the second lumen to the distalend of the catheter is also about 10 mm. In the illustrated embodimentthe connector must be rotated to a position where it is orientedorthogonally relative to the wall of the lumen. This may requirerotation through an angle of between 70 degrees and 110 degrees.

The implantation catheter 46 and valve 10 can be housed within a tubularsheath 36, as illustrated in FIG. 5. When placed in the sheath 36, thevalve 10 can be housed within the sheath during positioning. Use of thesheath 36 provides for ease of insertion of the catheter 46 and thevalve 10 through a vessel to the region of the a vessel wall 14 at whichthe connector is to be inserted.

An alternate valve is illustrated in FIGS. 6 through 8 and is givengenerally as 58. The valve 58 can be a flexible thin walled pliable tube62. The tube 62 can be made with a silicone material. The tube 62 can beimplanted coaxially into a vessel having a vessel wall 14. The tube 62can be attached to the lumen surface region or vessel wall 14 at a base66 by a connector or attachment mechanism 12. Preferably, the tube 62 isconnected to the vessel wall 14 at a single point. The tube 62 includesa proximal opening 70 and a distal opening 56. The distal end of tub 62can be reinforced using a frame or a thicker material, for example, toimprove the stability of the attachment.

In FIG. 6, when fluid flow 60 travels from a distal source, such asduring venous flow, the fluid will flow through a distal portion 56 ofthe tube 62. In the case of such flow, the walls 64 of the tube 62 canbe separated. Such separation of the walls 64 of the tube 62 allowsfluid to flow from a distal source through the proximal opening 70 inthe tube.

In FIGS. 7 and 8, in the case of flow in an opposite direction 68, suchas from a proximal source, the flow 68 can cause the tube 62 to collapseat its proximal end. The flow 68 then gradually collapses the tube 62from its proximal to its distal end. Collapse of the walls 64 of thetube 62 at the proximal end of the tube 62 can cause flow interruptionor reduction in this fluid flow 68. In such a case, closure of the walls64 of the tube 62 can prevent back flow 68 of the fluid 68 towards adistal source. Collapsing of the tube 62 at its proximal end reduces thecross sectional area of the opening 70 of the tube 62, as shown in FIG.8.

FIGS. 9A-9B and 10A-10B illustrate various configurations of the tube62. FIGS. 9A and 9B illustrate the valve 58 as a wedge shaped tube 72.The wedge shaped tube 72 can be occluded by retrograde flow or flow froma proximal source which forces the walls 64 of the tube 72 against eachother, thereby closing the tube 72.

FIGS. 10A and 10B illustrates a valve 58 which is a curve shaped tube74. The tube 74 includes a crease portion 76. The curve shaped tube 74can prevent flow from a retrograde or a proximal source in differentways. For example, when the tube 74 is exposed to a retrograde flow, thewalls of the tube 74 can close against each other, thereby closing thetube 74. Also for example, when exposed to retrograde flow, the tube 74can tilt and kink along the crease portion 76, thereby forcing theproximal portion of the tube 74 sidewards to create an occlusion andprevent backflow.

Another alternate valve design is shown in FIGS. 11 through 13 and isgiven generally as 80. The valve 80 includes a leaflet 82, a hinge 84and a base 86. The valve element 82 can be cast from a siliconematerial. The valve can be made from other materials describedpreviously herein. Preferably, the valve element 82 has an oval shape.The base 86 and the valve element 82 can be connected together by thehinge 84. The hinge 84 can be made from a variety of materials. Forexample, the hinge 84 can be a Nitinol hinge material. The hinge 84 canalso be made from a bundle of fibers, such as Kevlar™, glass or atextile, for example. Preferably, the rim of the leaflet 82 is thinnerthan the center portion of the leaflet 82 as illustrated in FIG. 12. Thebase 86 can have a size of about the size of a blood vessel. The base 86can be attached to a lumen surface region by an attachment mechanism orconnector. The leaflet 82 of the valve 80 can have a soft rim which canbe silicone to increase surface contact area. It can also help to sealthe valve against the vessel wall 14.

A reinforcement or frame member 88 can be imbedded into the valve toprovide for stabilization. The frame member 88 can be a metal filament,for example, and can be made from a stainless steel material. Theleaflet 82 and the base 86 can be connected together at an angle 92.When placed in a vessel, the angle 92 ensures that the valve 80 isclosed when there is no flow within the vessel. In the area of the hinge84, there is a thin layer of silicone to facilitate the rotation of thehinge 84. Alternatively the hinge can be used without silicone. Theleaflet 82 and the base 86 can be connected with a fabric material 94such as a woven textile. The member 88 can be mounted within the fabric94 or the leaflet material or a combination of layers of differentmaterials. The member 88, in combination with the fabric 94, providesstability to the valve 80 and allows the valve to be made from a thinmaterial.

FIG. 13 illustrates an alternate embodiment of the valve shown in FIG.11. In this embodiment, the leaflet 82 is formed in a concaved shape.With a concave shape, the edges of the leaflet 82 are thicker than thecenter of the leaflet 82. In such a valve 80, the valve 80 can bereinforced by a silicone rim rather than a metal rim.

The leaflet of the valve can also have a circular shape. The circularshaped valve can include a stopper. The stopper can prevent the leafletfrom being moved from a proximal position to a distal position about theaxis of the hinge. The stopper can be formed with or attached to eitherthe leaflet and/or the base and prevents rotation of the leafletrelative to the base beyond a certain angle.

FIG. 14 illustrates a valve 80 having a leaf or leaflet 82 and a base86. The leaflet 82 and the base 86 can be connected by a hinge 84. FIG.14 shows the area of the hinge 84 between the base 86 and the leaflet82. The leaflet 82 and the base 86 can be made from a silicone material100. At the hinge 84, the silicone material 100 can be thinner than thesilicone material on either the base 86 or the leaflet 82. The thinamount of silicone material 100 can facilitate movement of the hinge 84.The silicone 100 can be reinforced with a reinforcing material 88,located in the center of the silicone material 100. The reinforcementstructure 88 can extend through the hinge 84 from the base 86 to theleaflet 82. The material properties of the reinforcing material 88 canbe such that the material does not incur fatigue fractures over time.The reinforcing material can be a weaved structure, for example. Thefilaments of the weave structure can be very thin in order to provide ahigh resistance to fractures. For example, textile filaments can be usedas the reinforcing material. Also, Kevlar™can also be used as a filamentmaterial, for example. The hinge 84 can be a formed metal material inorder to interconnect the base 86 with the valve 82.

FIGS. 15-24 illustrate alternate embodiments of the valve 58 shown inFIGS. 7-10. The valve, illustrated in FIGS. 15-18, is given generally as110. The valve can include a proximal end 114 and a distal end 116. Thevalve 110 can be connected to a vessel wall 14 with at least oneconnection mechanism 12. Preferably, two connection mechanisms 12 areused to secure the valve 110 to the wall 14. The valve 110 can alsoinclude a proximal opening 118 and a distal opening 120. The valve 110can have a valve wall 130. The thickness of the valve wall 130 can varyfrom the distal end 116 to the proximal end 114 such that the thicknessof the wall 130 is thicker at the distal end 116 and thinner at theproximal end 114.

The proximal opening 118 can be formed longitudinally in the valve 110and can open and enlarge its cross section in the presence of flow froma distal source. FIG. 16 illustrates the proximal opening 118 of thevalve 110 along line A—A in a closed position. The proximal opening 118can include a rim 124. The rim 118 can also include a reinforcementstructure 122 which can provide a constant folding of the proximalopening 118 and the reinforcement material 122. Also, the reinforcementmaterial 122 can prevent a prolapse of the valve 110 backwards beyondthe attachment 112 to the wall 114. When flow or pressure comes from aproximal direction, the proximal opening 118 and the rim 124 of theproximal opening 118 can be pressed together thus preventing backflow.

FIGS. 17 and 18 illustrate the valve 110 in an open position. FIG. 18illustrates the opening at the valve 110 along line B—B of FIG. 17. Toachieve an open position, flow from a distal source can travel throughthe distal end 116 and through the proximal end 116 thereby forcing openthe proximal opening.

As shown in FIGS. 15 and 17, the valve 110 can include a partial slitthat extends longitudinally which allows for radial expansion of thevalve. The slit 112 can be located at the distal end 116 of the valve110. The diameter of the vessel wall 14 can change with pressure.Therefore, it is necessary that the wall 125 of the valve 110 be able toaccommodate these changes in circumference without stressing the wall ofthe vessel 14. Such stressing can create thrombosis or intimalhyperplasia.

The slit or opening 112 can be axially formed. Embodiments of theopening 112 are shown in FIGS. 19, 20A and 20B. FIG. 19 illustrates across section of the valve 110 wherein the opening 112 is an overlapping126 of the wall 130 of the valve 110. With the overlapping 126, thevalve 110 can expand and contract in relation to the expansion andcontraction of the vessel wall 14. With this overlapping 126, leakage ofthe venus blood through the opening 112 is reduced or eliminated. FIGS.20A and 20B illustrate an alternate opening 112 that is a longitudinalfold 128 within the valve 110. The fold 128 allows the expansion andcontraction of the wall 130 of the valve 110 during changing of diameterof the vessel wall 14. FIG. 20A illustrates the fold 128 in a closedposition or a folded position. FIG. 20B illustrates the fold in an openposition. The radially expanding valve of the present embodiment canalso be formed using an elastic material for at least a distal portionof the valve to the connectors.

FIGS. 21-24 illustrate an alternate valve as shown in FIGS. 15-18. Thevalve is given generally as 134. The valve 134 can have a concave curvedportion 138 and can attach to a vessel wall 14 by a plurality ofconnectors 12. FIG. 21 illustrates the valve 134 in the presence of noflow with no pressure gradient on the valve 134 or flow through thevalve 134. FIG. 22 illustrates the valve 134 having flow 136 travelingfrom a distal portion 116 to a proximal portion 114. The flow 136 canforce open the proximal portion 116 of the valve 134 thereby allowingfluid to flow through the valve 134. FIG. 23 illustrates the valve 134in the presence of flow or pressure 140 coming from a proximaldirection. In the presence of flow or pressure 140 from a proximaldirection, the rims 148 of the valve 134 can close and align together.Also, the area of closure which can relate to the surface area of thevalve 134 exposed to the flow or pressure can become larger than thearea shown in FIG. 21. The area of closure is given generally as 149.With a larger area of closure 149, the flow or pressure 140 has agreater surface area to push against, thereby causing the bending of thevalve 134 along the concave curved portion 138. The valve 134 can alsobe closed by the upper rim of the valve 134 pressing against the lowerrim to provide closure of the valve 134.

FIG. 24 illustrates an alternate embodiment of the valve 134 wherein thevalve 134 has a kink portion 142. With an increase in proximal pressureor flow 140 relative to the valve 110, the kink portion 142 of the valve134 can be forced to close and create a tight closure of the valve 134.The valve 134 can include a flexible material at the kink portion 142 toprevent fatigue fracture which can, in turn, destroy the valve 134. Inaddition to the kink portion 142, backflow can also be prevented by therim 124 of the opening 118 of the valve 134 closing together. Backflowcan also be prevented by the large area of closure 149 in thisembodiment of the valve 134.

FIG. 25 illustrates an attachment mechanism 150 for a valve 160 whichcan attach a valve 160 to a venous wall 14. The attachment mechanism 150can include a cannula 152, a catheter 156 and a sheath 164. The cannula152 can include an aperture 154 through which a fluid can betransmitted. The cannula can be a needle and can be made from a metalmaterial. The catheter 156 can be curved to form an arch shape. Such anarch or curve shape can allow ease of insertion of a valve element 160into a vessel wall 14. The catheter 156 can also include a shoulder 158.The shoulder 158 can abut the base 172 during an insertion process. Theshoulder can prevent the base 172 from moving during curing of anadhesive inserted at aperture 154. The catheter 156 can be introducedinto a vessel wall 14 through the sheath 164. The lumen of the catheter156 can be filled with a fluid such as a contrast material 166 whichallows a user to visualize the connector 150 in a vessel wall 14 duringan insertion procedure. The contrast material can give either a negativeor a positive contrast during imaging. The imaging can be x-rayfluoroscopy, for example. The negative contrast material 166 can be agas, such as carbon dioxide. A positive contrast medium can preferablybe a non-ionic contrast medium. The lumen of the catheter 156 can alsobe used to introduce a fluid such as an adhesive to secure the base 172to the wall 14 and can include a fluid such as a glucose solution whichcan force the adhesive through the catheter 156.

To insert a valve in a vessel wall 14, the valve 150 can be mounted tothe end of the pre-bent catheter 156. The valve 150 can be mountedaround the cannula 152. The base 172 of the valve can be mounted overthe cannula 152 to the catheter and can be secured by the shoulder 158.

To attach the valve 160 to a venous wall 14, the wall 14 can bepunctured by the tip of the cannula 152. The base 172 of the valve 160can include a secondary connector or attachment mechanism 34 to helpsecure the valve 160 to the wall 14. The base 172 can also form achamber 170 between the base 172 and the vessel wall 12. The base 172can include a rim 168 which can prevent spilling of the adhesive intothe lumen of the vessel. The lumen of the catheter 156 can then befilled with a negative or positive contrasting material 166. Afterhaving filled the lumen of the catheter, a small amount of adhesivematerial 162 can be introduced in the catheter. This amount of adhesivematerial 162 corresponds to the volume of a chamber 170 to preventspilling of flue into the circulatory system and the possibility of aresulting embolism. The adhesive can also be mixed with a contrastmedicine such as Lipidol (an only iodine contrast medicine). Otherbiocompatible glues such as Histocryl can be used. After the adhesive162 volume has been introduced, another fluid can be injected into thecatheter 156 such as a highly concentrated glucose solution or acontrast medium which does not introduce curing of the adhesive in thecatheter 156. The adhesive can leave the catheter system through theaperture 154 of the cannula 152. The aperture 154 can be arranged at adistance from the catheter shoulder 158 in such a manner that theaperture 154 can be in the chamber 170 below the base 172 of the valve160 and between the base 172 of the valve 160 and the arterial or venouswall 14. After curing of the adhesive, the catheter 156 with the cannula152 can be pulled outward leaving the valve 160 secured to the vesselwall 14.

As an alternate to using a cannula, a metal tube can be introducedthrough the catheter 156. The metal tube can include a closed tip and anaperture 154. The metal tube can have a stopper to adjust the positionof the aperture 154 to the position where the adhesive material (eg.Nitional™) has to be delivered. The metal tube can consist of a nickeltitanium material and can be bendable. The tube can be used for otherpurposes also, such as to adjust dissections after angioplasty to thebase of the vessel wall while gluing.

The distance between the aperture of the metal tube and the end ofcatheter can be longer, thus allowing injection of drugs into theperivascular tissue for the prevention of intimal hyperplasia. Afterinjection of the drug, the puncture hole can be closed with a smallamount of adhesive to inhibit perivascular bleeding and back leakage ofdrug into the vessel lumen.

Alternately, the base 172 of the valve 160 can include a self adhesiveto secure the base 172 to the vessel wall 14. The valve 160 can bedelivered to an attachment site using an attachment mechanism. The valve160 can then be secured to the vessel wall 14 by contacting the selfadhesive with the wall 14. After curing of the self adhesive, theattachment mechanism can be removed from the attachment site.

While this invention has been particularly shown and described withreferences to preferred embodiments thereof, it will be understood bythose skilled in the art that various changes in form and details may bemade therein without departing from the scope of the inventionencompassed by the appended claims.

What is claimed is:
 1. A body lumen valve comprising: a base; a valveelement comprising tissue disposed on a mesh, said valve elementconnected to the base such that the valve moves relative to the basebetween an open position and a closed position; and a connector thatattaches the base directly to a body lumen surface region.
 2. The valveof claim 1 wherein the valve element comprises a rim formed of aflexible material.
 3. The valve of claim 1 wherein the valve elementcomprises at least one valve.
 4. The valve of claim 1 wherein the valvefurther comprises a second connector.
 5. The valve of claim 1 whereinthe connector comprises a pin, a screw or a staple.
 6. The valve ofclaim 1 wherein the valve element further comprises a leaflet attachedto a frame.
 7. The valve of claim 1 wherein the valve element and thebase comprise a unitary structure having a hinge such that the valveelement rotates relative to the base at the hinge.
 8. The valve of claim1 wherein the valve element comprises a substantially circular memberhaving a soft peripheral rim.
 9. The valve of claim 1 wherein the valveelement has a thickness in a range between 0.2 mm and 3.0 mm, and adiameter in a range between 2 mm and 25 mm.
 10. The valve of claim 1,wherein said tissue is cultured onto the valve element prior toimplantation into a surgical site.
 11. The valve of claim 1 wherein saidtissue is adhered to the mesh after implantation into a surgical site.12. A valve comprising: a base; a connector that attaches the basedirectly to a body lumen surface region; and a tubular wall attached tothe base, the tubular wall formed of a silicone material and having adistal end with a distal opening and a proximal end with a proximalopening such that fluid flow from the distal end to the proximal endforces the tubular wall into an open position and fluid flow from theproximal end to the distal end forces the tubular wall into a closedposition.
 13. The valve of claim 12 wherein the proximal openingcomprises a rim.
 14. The valve of claim 12 wherein the proximal openingcomprises at least one reinforcement member.
 15. The valve of claim 12wherein the valve comprises a radially expanding region.
 16. The valveof claim 15 wherein the radially expanding region comprises anoverlapping portion.
 17. The valve of claim 15 wherein the radiallyexpanding region comprises a longitudinal fold.
 18. The valve of claim12 wherein the valve further comprises a concave curved portion.
 19. Animplantable venous valve comprising: a base; a connector that attachesthe base directly to a body lumen surface region; a leaflet comprising arim and a center portion, the rim being thinner than the center portion;and a hinge connecting the base to the leaflet such that the leafletmoves relative to the base between an open position and a closedposition.
 20. The valve of claim 19 wherein the leaflet comprises anoval shape.
 21. The valve of claim 19 wherein the leaflet comprises aconcave shape.
 22. The valve of claim 19 wherein the valve comprises aframe.
 23. The valve of claim 22 wherein the frame comprises a metalfilament.
 24. The valve of claim 19 wherein the valve is formed of asilicone material.
 25. The valve of claim 19 wherein the valve furtherhas a fabric material connecting the leaflet and the base.
 26. The valveof claim 19 wherein a frame is located between a first layer and asecond layer of the leaflet.
 27. The valve of claim 19 wherein theleaflet comprises a mesh.
 28. The valve of claim 27 wherein the meshcomprises a surface formed of cells.
 29. The valve of claim 28 whereinthe cells are cultured onto the mesh.
 30. The valve of claim 28 whereinthe cells adhere to the mesh after implantation into a surgical site.31. An implantable venous valve comprising: a base; a connector thatattached the base to a lumen surface region; a leaflet; and a hingeconnecting the base to the leaflet such that the leaflet moves relativeto the base between an open position and a closed position, wherein saidvalve is formed of a silicone material.
 32. The valve of claim 31wherein the leaflet comprises an oval shape.
 33. The valve of claim 31wherein the leaflet comprises a rim and a center portion, the rim beingthinner than the center portion.
 34. The valve of claim 31 wherein theleaflet comprises a concave shape.
 35. The valve of claim 31 wherein thevalve comprises a frame.
 36. The valve of claim 35 wherein the framecomprises a metal filament.
 37. The valve of claim 31 wherein the valvefurther has a fabric material connecting the leaflet and the base. 38.The valve of claim 31 wherein a frame is located between a first layerand a second layer of the leaflet.
 39. The valve of claim 31 wherein theleaflet comprises a mesh.
 40. The valve of claim 39 wherein the meshcomprises a surface formed of cells.
 41. The valve of claim 40 whereinthe cells are cultured onto the mesh.
 42. The valve of claim 40 whereinthe cells adhere to the mesh after implantation into a surgical site.